Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection.

Journal Article (Clinical Trial;Journal Article)

BACKGROUND & AIMS: Patients with hepatitis C virus (HCV) infections who achieve a sustained virologic response (SVR) to treatment have improved patient-reported outcomes (PROs). We compared post-treatment PRO scores between patients with chronic HCV infection who did and did not achieve an SVR to treatment. METHODS: Patients who completed treatment in clinical trials were enrolled in 2 registries, depending on the treatment outcome (NCT01457755, NCT01457768), from 2016 to 2017 in 17 countries in North America, Europe, and the Asia-Pacific region. PRO scores (scale, 0-100) were collected at pretreatment (baseline); the last day of treatment; the post-treatment week 12 follow-up visit (in patients with SVR only); the registry baseline; and on registry weeks 12, 24, 36, 48, and 96 (the non-SVR registry) or every 24 weeks until week 96 (SVR registry), using the Short Form-36 (SF-36) instrument. RESULTS: Our analysis included 4234 patients with an SVR and 242 without an SVR from whom pretreatment PRO data were available (mean age, 54 ± 10 y; 63% male; 65% enrolled in the United States; 17% with cirrhosis; 12% with human immunodeficiency virus co-infection). Upon registry enrollment, patients with an SVR had significant increases in all PRO scores compared with pretreatment baseline levels (all P < .05). Patients without an SVR had mean reductions of 9.2 points or less in PRO scores while followed up on the registry (P < .05 for 4-8 of 8 PRO domains measured by the SF-36). In contrast, patients with an SVR had sustained increases in PRO scores (mean increase, ≤7.0 points) while on the registry. In multivariate analysis, achieving an SVR was associated independently with superior scores in all SF-36 domains at all registry time points (β, +4.8 to +15.9 points, all P ≤ .01). CONCLUSIONS: In a follow-up analysis of participants in clinical trials, we found that those with an SVR to treatment for HCV infection had significant increases in well-being, based on PRO scores. Patients without an SVR had decreasing PRO scores over the follow-up period.

Full Text

Duke Authors

Cited Authors

  • Younossi, ZM; Stepanova, M; Racila, A; Afendy, A; Lawitz, EJ; Schwabe, C; Ruane, PJ; Lalezari, J; Reddy, KR; Jacobson, IM; Muir, AJ; Gaggar, A; Myers, RP; Younossi, I; Nader, F

Published Date

  • February 2020

Published In

Volume / Issue

  • 18 / 2

Start / End Page

  • 468 - 476.e11

PubMed ID

  • 31376493

Electronic International Standard Serial Number (EISSN)

  • 1542-7714

Digital Object Identifier (DOI)

  • 10.1016/j.cgh.2019.07.047

Language

  • eng

Conference Location

  • United States